ISO 15223-1:2021

Overview

ISO 15223-1:2021 - "Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements" defines internationally recognized symbols for conveying manufacturer-supplied information for medical devices. The fourth edition (2021) updates the symbol set and terminology and is intended for use on medical devices, packaging and accompanying information (e.g., instructions for use, labels, GUIs). The standard facilitates consistent, language‑independent communication to meet diverse global regulatory requirements.

Key topics and technical requirements

• Scope and purpose: Specifies symbols used to express information supplied by the manufacturer; it does not prescribe what information must be supplied.
• Symbol definitions and descriptions: Provides normative symbol definitions, meanings and usage guidance.
• General requirements for use: Rules for application of symbols on devices, packaging and accompanying information, including considerations for clarity and context.
• Validation and development: Symbols included have been sourced from ISO 7000, ISO 7001, IEC 60417 or validated via formal processes (see ISO 15223-2 for development/validation details).
• Terminology alignment: Incorporates defined terms from related standards (e.g., ISO 20417, ISO 13485, ISO 14971) to ensure consistent interpretation across documentation.
• Annex guidance: Informative annexes (Annex A and B) give examples of symbol combinations, negation and prohibition use, and practical implementation tips.
• Normative references: Includes references such as ISO 3166‑1 and ISO 8601 parts relevant to standardized coding and date/time representations.

Applications and who uses it

ISO 15223-1:2021 is practical for:

• Medical device manufacturers - to label products and create multilingual‑neutral instructions for use.
• Regulatory affairs and compliance teams - to demonstrate harmonized symbol use across markets.
• Design and human factors engineers - to integrate symbols into device GUIs, packaging and printed materials.
• Quality and labeling specialists - to maintain consistent product identification (catalogue number, lot/batch codes) and safety information.
• Distributors, importers and healthcare providers - to interpret device information reliably without translation.

Benefits include reduced translation errors, streamlined global market access, and consistent safety communication across supply chains.

Related standards

• ISO 15223-2 (symbol development, selection and validation)
• ISO 20417 (information supplied by the manufacturer)
• ISO 13485, ISO 14971 (quality management, risk management)
• ISO 3166-1, ISO 8601 (coding and date/time formats)
• ISO 7000, ISO 7001, IEC 60417 (symbol repositories)

Keywords: ISO 15223-1:2021, medical device symbols, labeling, instructions for use, packaging, symbol validation, regulatory compliance, ISO medical device standards.